ALL-20249 Juvedermit folder

HIGH PATIENT SATISFACTION 2

IT’S TIME TO SCULPT IT

94% (N=85) of patients reported satisfaction improvement from baseline with their chin at 3 months after Juvéderm® VOLUX treatment.2,*

1

For illustrative purposes only.

The majority of injection site responses were mild to moderate in severity and generally resolved within 1 week after treatment.7

months

The latest injectable gel in the VYCROSS® collection,1 part of the world’s number one brand of hyaluronic acid (HA) facial fillers8,*

Restores and creates facial volume, allowing you to improve the G-Sn-Pog angle and chin projection2

May give patients and physicians visible, lasting and satisfactory results for 18–24 months2,5,†

* Based on healthcare professional (HCP) tracking market research, from over 1000 HCPs in the largest 13 aesthetic markets worldwide. 8 † Based on comparative preclinical in vitro testing and results from repeat treatment data, added to Juvéderm® VOLUX clinical study showing duration beyond 18 months after initial treatment or initial + top-up treatment in the chin and jaw, as well as clinical results for predicate device Juvéderm® VOLUMA with lidocaine showing 24 month duration in the mid-face established Juvéderm® VOLUX as having an in situ duration of 18–24 months. 4

1. Juvéderm® VOLUX DFU. 72778JR10. Revision 2018-07-26.

2. Allergan. Data on File. INT/0654/2018. Juvéderm® VOLUX final clinical study report & clinical evaluation report – efficacy and duration data. Oct 2018.

3. Ogilvie P et al. Poster Presentation at Aesthetic & Anti-Aging Medicine World Congress (AMWC), Monte Carlo, Monaco; 2018.

4. Raspaldo H et al. J Cosmet Dermatol. 2010;9:11–15.

5. Allergan. Data on File. INT/0074/2019. Juvéderm® VOLUX final clinical evaluation report, July 2018. Jan 2019.

6. Allergan. Data on File. INT/0663/2018. Juvéderm® VOLUX final clinical evaluation report. Oct 2018.

7. Allergan. Data on File. INT/0661/2018. Juvéderm® VOLUX final clinical study report – safety data. Oct 2018.

8. Allergan. Unpublished Data. INT/0771/2016(2). JUVÉDERM ®, the world’s leading brand of hyaluronic acid facial fillers. Feb 2019.

Allergan Norden AB, Strandbergsgatan 61, 112 51 Stockholm, Sverige To report Adverse Events please contact: ProductSurveillance_EAME@Allergan.com

N = total sample number. * Additional effectiveness analyses: patients reporting improvement from baseline on 3 modules of the FACE-Q questionnaire (Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being). 2

with Juvéderm® VOLUX 1,*

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ND/0219/2019. Date of preparation: May 2019.

94%

18–24

When you want to define the lower face1–3,† Model treated with JUVÉDERM ®. Results may vary.

Juvéderm ® VOLUX is an injectable implant intended to restore and create volume of the face.1 * Juvéderm ® VOLUX contains lidocaine.1 The addition of lidocaine does not alter the product’s physical properties. 4 † Clinical study assessed lower face as chin and jaw area. 2

AN EVOLUTION WITHIN THE VYCROSS ® COLLECTION

VISIBLE RESULTS THAT LAST 2,5 100% of physicians (N=83) and 91.8% of patients (N=85) rated facial volume as ‘improved’ or ‘much improved’ in the chin and jaw area at 3 months after Juvéderm® VOLUX treatment.2,3,*,†,‡,§

After Juvéderm® VOLUX treatment, results may still be noticed by physicians and patients for 18–24 months.2,5,*,‡,¶

Continued effectiveness beyond 18 months2

GlabellaGlabella (G) (G)

Subnasale Subnasale (Sn) (Sn) G-Sn-Pog G-Sn-Pog Pogonion Pogonion (Pog) (Pog)

100

Juvéderm® VOLUX

Patient assessment

100 91.8

83.5

80

3

77.2 62.0

60

3.5

93.8

96.9

Mean change in G-Sn-Pog angle from baseline (degree)

It has been designed to enhance lift capacity in comparison to Juvéderm® VOLUMA,6 to allow improvement in the G-Sn-Pog angle, facial volume and chin projection.2,3

Investigator assessment Global Aesthetic Improvement Scale (GAIS) responder rate (% improved or much improved)§

Juvéderm® VOLUX has been designed to restore and create volume in the chin and jaw area2,* and results may be seen for 18–24 months.2,5,†

Mean change in G-Sn-Pog angle from baseline2

52.5

40 20

2.5

Control 3.14

2.73 2.12

2 1.5

1.26

1

1.15

0.5 0

-0.21

-0.38

-0.5 -1

0 Month 3

Month 12

Month 18

N=83 N=85

N=79 N=79

N=80 N=79

Time after treatment

Month 1 after repeat treatment N=64

N=65

Month 1

Month 3

Month 12

Month 18

N=86 N=29

N=85 N=29

N=75

N=78

Month 1 after repeat treatment N=65

Time after treatment

Both graphs adapted from Allergan. Data on File. INT/0654/2018. 2 N = total sample number.

‡ Top-up treatment was given to 69/90 patients. 2 N = total sample number. § The GAIS responder rate was a secondary endpoint .2 Other effectiveness measures included 3D volumetric data (change in volume since baseline) from analysis of digital images of the subject’s facial profile, distance measurements of change in chin projection from analysis of digital images of the subject’s facial profiles, and subject responses on 3 modules of the FACE-Q questionnaire (Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and the Psychological Well-being).2

* Clinical study assessed lower face as chin and jaw area. 2

* This was a prospective, multicentre, single-blind, randomised, controlled study evaluating the effectiveness of Juvederm® VOLUX in restoring and creating facial volume in the chin and jaw area, and sculpting, shaping, and contouring across the pogonion, mentum, pre-jowl sulci (left and right), and sublabial (mental) crease. Treatment group (N=90) were given Juvederm® VOLUX from the start of the study; control patients had treatment delayed by 3 months. Treatment occurred at up to 2 visits (initial and top-up) approximately 30 days apart based on the investigator’s clinical experience. Patients returned for follow-up visits to assess safety and effectiveness at Month 1, 3, 6, 9, 12, 15, 18, 21, and 24 after the last treatment. 2

† Based on comparative preclinical in vitro testing and results from repeat treatment data, added to Juvéderm® VOLUX clinical study showing duration beyond 18 months after initial treatment or initial + top-up treatment in the chin and jaw, as well as clinical results for predicate device Juvéderm® VOLUMA with lidocaine showing 24 month duration in the mid-face established Juvéderm® VOLUX as having an in situ duration of 18–24 months. 4

† Primary endpoint: comparison of the mean change in facial angle from baseline between Juvéderm® VOLUX and control patients at 3 months based on 3D facial digital imaging (conducted at all visits). A treatment-blinded image-analysis technician calculated all angle assessments performed based on glabella, subnasale, and pogonion landmarks set by the investigator in digital images captured at screening.6

For illustrative purposes only.

G-Sn-Pog, glabella-subnasale-pogonion.

¶ Based on comparative preclinical in vitro testing and results from repeat treatment data, added to Juvéderm® VOLUX clinical study showing duration beyond 18 months after initial treatment or initial + top-up treatment in the chin and jaw, as well as clinical results for predicate device Juvéderm® VOLUMA with lidocaine showing 24 month duration in the mid-face established Juvéderm® VOLUX as having an in situ duration of 18–24 months. 4